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Tiziana Life Sciences Plans to Submit IND for Phase 1 Trial of Intranasal Foralumab in Alzheimer's Disease Patients
Company continues to advance foralumab in CNS-related inflammatory diseasesNEW YORK, Oct. 12, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq:
About this update from Tiziana Life Sciences Ltd
[{"type":"text","content":"Company continues to advance foralumab in CNS-related inflammatory diseasesNEW YORK, Oct. 12, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that it plans to submit an Investigational New Drug Application (IND) for a Phase 1 Trial of intranasal foralumab in Alzheimer's disease patients after receiving an affirmative written response from the FDA on a Pre-Investigational New Drug Application (PIND). Tiziana plans on filing the IND for Alzheimer’s disease by the third quarter of 2023 upon the completion of requested toxicology studies, then starting its Phase 1 program by the end of 2023. “I am thrilled to see the company advancing foralumab into another promising central nervous system (CNS) -related therapeutic area with high unmet need,” commented Gabriele Cerrone, Executive Chairman and interim Chief Executive Officer of Tiziana Life Sciences. “Intranasal foralumab’s unique action on regulatory T-cells should allow us to study multiple CNS inflammatory pathology indications for this unique drug, including in Multiple Sclerosis (MS) and Amyotrophic Lateral Sclerosis (ALS).” “We have spent years studying intranasal anti-CD3, or foralumab, in inflammatory CNS-related disease models in animals,” said Howard L. Weiner, M.D., Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital. “We look forward to evaluating intranasal foralumab in patients with early symptomatic Alzheimer’s disease, where we believe its locally acting anti-inflammatory mechanism of action will be relevant.” “Tiziana strongly believes that many inflammatory CNS disease pathologies could improve with intranasally administered foralumab and as such, we hope to study additional neurological disease states over time,” stated Matthew Davis, M.D., RPh, Chief Scientific Officer and Chief Medical Officer of Tiziana Life Sciences. About Foralumab Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, has shown reduced release of cytokines after IV administration in healthy volunteers and in patients with Crohn's disease. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that while targeting the T-cell receptor, orally administered foralum...